The updated, “bivalent” booster vaccine - made by Pfizer/BioNTech - will target both the original strain of the virus and the Omicron variant, and has been approved for use in those aged 12 and above.
The new jab was approved the Medicines and Healthcare products Regulatory Agency (MHRA) on Saturday after it was found to meet the UK regulator’s standards of safety, quality and effectiveness.
MHRA Chief Executive Dr June Raine said: “I am pleased to announce that we now have a second approved vaccine for the UK Autumn booster programme. The clinical trial of the Pfizer/BioNTech bivalent vaccine showed a strong immune response against the Omicron BA.1 variant as well as the original strain.
“Bivalent vaccines are helping us to meet the challenge of an ever-evolving virus, to help protect people against COVID-19 variants.
“We have in place a comprehensive safety surveillance strategy for all UK-approved Covid-19 vaccines, and this will include the updated booster we approved today.”
In each dose of the booster vaccine, half of the vaccine targets the original strain of the virus while the other half targets the Omicron variant.
The MHRA’s decision follows a clinical trial which showed a booster dose with the bivalent vaccine triggers a strong immune response against both strains of the virus.
Safety monitoring showed side effects observed were the same as those seen for the original Pfizer/BioNTech booster dose and were typically mild and self-resolving, and no new serious safety concerns were identified.
The new vaccine will be offered as part of an autumn booster programme which is being rolled out on Monday, and will see millions of people invited to receive a top-up dose.
It comes after another bivalent vaccine, manufactured by Moderna, was approved last month. It too targets the original strain, and the now-dominant Omicron variant.
Prof Sir Munir Pirmohamed, Chair of the Commission on Human Medicines, added: “Following an independent review of the safety, quality and effectiveness of the vaccine, the Commission on Human Medicines and its Covid-19 Vaccines Expert Working Group supports the MHRA’s decision.
“As with any medicinal product, including vaccines, it is important to continually monitor effectiveness and safety when it is deployed, and we have the relevant processes and expertise in this country to do that.”
The groups who qualify for the booster programme are: adults aged 50 and over, people aged five to 49 with health conditions that put them at higher risk - including pregnant women, care-home staff, frontline health and social care workers, carers aged 16 to 49, and household contacts of people with weakened immune systems.